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Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen
ClinicalTrials.gov Identifier:
NCT00991211
First received: October 6, 2009
Last updated: March 13, 2012
Last verified: October 2009
History of Changes

October 6, 2009
March 13, 2012
January 2004
August 2009   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: observation 3 years or significant differences between two arms ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00991211 on ClinicalTrials.gov Archive Site
Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Bendamustine Plus Rituximab Versus CHOP Plus Rituximab
Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas

The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).

The 4 agent chemotherapy (CTX) CHOP (cyclophosphamide, doxorubicin, vincristine prednisone) in combination with the monoclonal anti-CD20 antibody rituximab (CHOP-R) represents a standard CTX for the treatment of lymphomas of high or low malignancy. The combination of bendamustine and rituximab (B-R) is also highly effective with a more advantageous toxicity profile. If B-R could be shown to be non inferior to CHOP-R, this could improve the quality of life of the patient and possibly also the prognosis.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin Lymphomas
  • Follicular Lymphomas
  • Immunocytomas
  • Lymphocytic Lymphomas
  • Marginal Zone Lymphomas
  • Drug: Bendamustine
    Comparison of Bendamustine + Rituximab with CHOP + Rituximab
    Other Name: Ribomustin, Treanda
  • Drug: Standard chemotherapy CHOP + Ritiximab
    Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w as standard Chemotherapy
    Other Names:
    • Endoxan(R), Cyclostin(R) = Cyclophosphamide
    • Adriamycin(R) Doxorubicin
    • Oncovin(R) Vincristine
    • Prednison
    • Rituxan(R), MabThera(R) = Rituximab
  • Experimental: Bendamustine + Rituximab
    Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
    Intervention: Drug: Bendamustine
  • Active Comparator: CHOP + Rituximab
    Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w
    Intervention: Drug: Standard chemotherapy CHOP + Ritiximab
Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Dürk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. doi: 10.1016/S0140-6736(12)61763-2. Epub 2013 Feb 20. Erratum in: Lancet. 2013 Apr 6;381(9873):1184.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
549
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:

    • Follicular lymphoma grade 1 and 2
    • Immunocytoma and lymphoplasmocytic lymphoma
    • Marginal zone lymphoma, nodal and generalised
    • Mantle cell lymphoma
    • lymphocytic lymphoma (CLL without leucaemic characteristics)
    • non-specified/classified lymphomas of low malignancy
  • No prior therapy with cytotoxics,interferon or monoclonal antibodies
  • Need for therapy, except mantle cell lymphomas
  • Stadium III or IV
  • Written informed consent
  • Performance status WHO 0-2
  • Histology not older than 6 months

Exclusion Criteria:

  • Patients not establishing all above mentioned prerequisites
  • Option of a primary, potential curative radiation therapy
  • Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions

  • Comorbidities excluding a study conform therapy:

    • heart attack during the last 6 months
    • severe, medicinal not adjustable hypertonia
    • severe functional defects of the heart (NYHA III or IV)
    • lung (WHO grade III or IV), liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00991211
NHL 1-2003
Yes
Jurgen Barth, University of Giessen
University of Giessen
Not Provided
Principal Investigator: Mathias Rummel, Dr. Study Group of indolent Lymphom,as (StiL)
University of Giessen
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP